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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003432 |
RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support |
Estimated Enrollment: | 26 |
Study Start Date: | June 1998 |
OBJECTIVES:
OUTLINE: Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study. The dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests.
Patients are followed every 3 months for the first year and annually thereafter.
PROJECTED ACCRUAL: A total of 14-26 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA)
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Herbert K. Lyerly, MD | Duke University |
Study ID Numbers: | CDR0000066458, DUMC-97148, NCI-G98-1455 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003432 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |